Job Overview
The Principal Quality Engineer will be a key member of the Quality and Regulatory Affairs teams.
Responsibilities
1. Collaborate with the VP of Quality and Regulatory Affairs to develop and maintain a quality system in compliance with ISO 13485:2016 and the quality system regulation 21CFR Part820.
2. Manage document control processes to ensure consistency and compliance across all documents.
3. Represent the quality function at functional team meetings, providing guidance and completing documentation reviews in a timely manner.
4. Participate in risk management activities to identify and mitigate risks in accordance with ISO 14971:2019.
5. Liaise with technical operations to support the manufacture of high-quality devices in compliance with procedures and regulations.
6. Compile quality metrics for management meetings and review.
7. Address customer complaints in accordance with regulatory requirements, ensuring vigilance and reporting obligations are met.
8. Implement and manage CAPA systems to address observations comprehensively and efficiently.
9. Oversee computerised system validation in accordance with documented procedures and regulations.
10. Maintain an internal audit schedule, addressing non-conformances and recommendations in a timely manner.
11. Support the supplier management programme to ensure sub-contractors, suppliers, and external parties meet quality system requirements.
12. Prepare reports, documents, and specifications as required to support project success.
13. Contribute to the continuous improvement of quality system processes and the business generally.
14. Perform additional tasks assigned by your supervisor to support business needs.